The following patents are hereby incorporated by reference in their entirety: U.S. Pat. Nos. 7,618,432; 7,744,620; and 7,951,111.
This invention is related to balloon catheters used for locating a position within a blood vessel or tubular member of the body, dilating tissue found within the tubular member, and measuring the compliance characteristics of tissue or the tubular member. Specifically, this device is intended for locating the balloon across the aortic annulus and aortic sinus, dilating the diseased aortic valve leaflets, and measuring the compliance characteristics of the annulus or sinus region.
Currently cylindrically shaped balloons are used to perform valvuloplasty procedures wherein the stenotic aortic valve leaflets are dilated or pushed back into the space of the aortic sinus. This procedure is typically performed under fluoroscopic guidance while the heart is beating. Movement of the heart, flow of blood, and inaccuracies in of fluoroscopic guidance do not always allow for accurate placement of the valvuloplasty catheter across the aortic annulus and sinus.
Recently dog-bone-shaped balloons have been presented (see U.S. Pat. No. 7,618,432) that provide for improved positioning across the aortic annulus and sinus. Also, dog-bone-shaped balloons have been presented that are able to measure the diameter of the aortic annulus as well as indicate the compliance characteristics of the aortic annulus (see U.S. Pat. No. 7,951,111).
Dilation of the aortic valve leaflets into the aortic sinus can cause the sinus to become overly distended and potentially encounter dissection or tearing which can result in patient death. Under current fluoroscopic visualization the physician does not know when the balloon has made contact with the leaflets, does not know if the aortic sinus is being overdistended, and he does not have information indicating the compliance characteristics of the aortic sinus or annulus. Such information would be useful to the clinician to ensure safety to the patient during dilation of the stenotic aortic valve leaflets to obviate annulus and sinus dissection and to ensure adequate dilation of the leaflets.